Category: Statistics

Int J Periodontics Restorative Dent. 2023 Jun 22. doi: 10.11607/prd.6406. Online ahead of print.

ABSTRACT

This study aimed to clinically evaluate the efficacy of two different home whitening protocols and to determine which is more effective: applying the whitening gel every 24 hours or every 48 hours for 2 weeks. The differences in terms of tooth sensitivity are also analyzed. A sample of 60 patients was divided into three groups of 20 (N=20). Group A: 16% carbamide peroxide applied every 24h for 2 weeks. Group B: 16% carbamide peroxide applied every 48h for 2 weeks. Group C (control group): a placebo gel without peroxide (glycerin gel) was applied every 24h for 2 weeks. To compare the groups, color measurements were made using a spectrophotometer and Student’s t-test for independent samples was used. The confidence level was set at 95% (p ≤ 0.05) and no statistically significant differences between applying 16% carbamide peroxide every 24h or every 48h for 2 weeks (p> 0.05) were found. The study concluded that carbamide peroxide 16% is equally effective applied with both protocols, obtaining the same results, but the application of every other day protocol produces less sensitivity than the daily application protocol.

PMID:37347995 | DOI:10.11607/prd.6406

Science. 2023 Jun 23;380(6651):1222-1223. doi: 10.1126/science.adi0248. Epub 2023 Jun 22.

ABSTRACT

Models can convey biases and false information to users.

PMID:37347992 | DOI:10.1126/science.adi0248

Otolaryngol Pol. 2023 Jan 14;77(2):24-29. doi: 10.5604/01.3001.0016.2167.

ABSTRACT

<br><b>Introduction:</b> Injury of the external branch of the superior laryngeal nerve can cause a hoarse or weak voice due to the functional loss (dysergia) of the cricothyroid muscle. Defining the anatomical variations of the external branch of the superior laryngeal nerve and estimating their frequency are crucial for surgical interventions.</br> <br><b>Aim:</b> To reveal the topography of the external branch in the Anatolian population, to prevent injury of it during the surgical intervention in the anterior neck region.</br> <br><b>Material and methods:</b> 26 bilateral hemilarynges (4 females, 22 males) were dissected. The morphometric and morphological features of the external branch were examined. The obtained results were compared statistically, left and right.</br> <br><b>Results:</b> Landmarks such as the thyroid gland and laryngeal prominence were determined for the detection of the external branch. The variations of the course of the external branch and the points of piercing the cricothyroid muscle or inferior pharyngeal constrictor muscle were evaluated.</br> <br><b>Discussion:</b> Although safe approaches have been described for nerve protection during neck surgeries, injuries may occur during preliminary surgery as the mentioned nerve is thinner and more superficial than other branches of the vagus nerve. However, it can be detected more easily and safely by knowing the defined anatomical landmarks and morphological variations of the external branch.</br> <br><b>Conclusion:</b> The anatomical variations described can be a safe and important guide in surgeries of the anterior neck region.</br&gt.

PMID:37347976 | DOI:10.5604/01.3001.0016.2167

J Child Adolesc Psychopharmacol. 2023 Jun 22. doi: 10.1089/cap.2023.0018. Online ahead of print.

ABSTRACT

Background: Treatment of obsessive-compulsive disorder (OCD) in children and adolescents frequently involves cognitive behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), or their combination. However, how adding CBT to SSRIs affects the trajectory and magnitude of improvement has not been evaluated meta-analytically. Methods: We performed a meta-analysis using weekly data from prospective randomized parallel group trials of CBT and SSRIs in pediatric patients with OCD. Response was modeled for the change in the Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) using a Bayesian hierarchical model over 12 weeks. Results: Fourteen studies included pharmacotherapy arms, 4 studies included combined pharmacotherapy and psychotherapy, and 10 studies included a placebo or control arm. The studies included 1146 patients (mean age 12.7 ± 1.3 years, mean 42.1% female). In the logarithmic model of response, statistically significant differences in treatment effects for CBT+SSRI and SSRI monotherapy were observed compared with placebo (SSRI β = -3.59, credible interval [95% CrI]: -4.13 to -3.02, p < 0.001; SSRI+CBT β = -4.07, 95% CrI: -5.05 to -3.04, p < 0.001). Adding CBT to an SSRI produced numerically (but not statistically significantly) greater improvement over 12 weeks. Greater improvement was observed in studies with more boys (p < 0.001), younger patients (p < 0.001), and in studies with greater baseline symptom severity (p < 0.001). Conclusions: In children and adolescents with OCD, compared with placebo, both SSRIs and SSRI+CBT produced early and sustained improvement over 12 weeks, although the improvement was also related to sample characteristics. Longer term studies are needed to determine when the additive benefit of CBT emerges relative to SSRI monotherapy.

PMID:37347947 | DOI:10.1089/cap.2023.0018

J Strength Cond Res. 2023 Jul 1;37(7):1382-1389. doi: 10.1519/JSC.0000000000004422. Epub 2023 Jan 18.

ABSTRACT

Janicijevic, D, Pérez-Castilla, A, Miras-Moreno, S, Ortega-Becerra, M, Morenas-Aguilar, MD, Smajla, D, Sarabon, N, and García-Ramos, A. Effect of a high-intensity handball-specific fatigue protocol focused on the leg contralateral to the throwing arm on interlimb asymmetries. J Strength Cond Res 37(7): 1382-1389, 2023-This study aimed to elucidate which countermovement jump (CMJ) variant (unilateral or bilateral) is more sensitive to detect the decrement in kinetic CMJ-derived variables of the leg more actively involved in a handball-specific fatigue protocol. Seventeen female handball players (age: 20.6 ± 2.5 years) performed a fatigue protocol consisting of 8 repetitions of the following circuit separated by 10 seconds: 10 m sprint, 180° change of direction with the leg contralateral to the throwing arm, 10 m sprint with ball reception at 7 m, and handball throw preceded by a jump over a 40 cm hurdle with the leg contralateral to the throwing arm. Before and after the fatigue protocol, 6 unilateral CMJs (3 with each leg) and 3 bilateral CMJs were performed on a dual Kistler force platform (model 9260AA6). Bilateral CMJ height was reduced by 5.4% after the fatigue protocol (p < 0.001). However, the fatigue protocol did not promote any significant change in peak force, mean force, and propulsive impulse or in their asymmetry values (17 of 18 comparisons). The decrement of 6.1% during the unilateral CMJ in the propulsive impulse developed by the leg ipsilateral to the throwing arm (less involved in the fatigue protocol) was the only variable that reached statistical significance (p = 0.038). The pre-post fatigue changes in asymmetry values presented negligible correlations between both CMJ variants (rs = 0.01 to -0.19). These results suggest that neither unilateral nor bilateral CMJs are able to detect changes in interlimb asymmetries after a high-intensity handball-specific fatigue protocol.

PMID:37347942 | DOI:10.1519/JSC.0000000000004422

JMIR Res Protoc. 2023 Jun 22;12:e46808. doi: 10.2196/46808.

ABSTRACT

BACKGROUND: Research and policy demonstrate the value of and need for systematically identifying and preparing care partners for their caregiving responsibilities while their family member or friend living with dementia is hospitalized. The Care Partner Hospital Assessment Tool (CHAT) has undergone content and face validation and has been endorsed as appropriate by clinicians to facilitate the timely identification and preparation of care partners of older adult patients during their hospitalization. However, the CHAT has not yet been adapted or prospectively evaluated for use with care partners of hospitalized people living with dementia. Adapting and testing the CHAT via a pilot study will provide the necessary evidence to optimize feasibility and enable future efficacy trials.

OBJECTIVE: The purpose of this paper is to describe the study protocol for the adaptation and testing of the CHAT for use among care partners of hospitalized people living with dementia to better prepare them for their caregiving responsibilities after hospital discharge.

METHODS: Our protocol is based on the National Institutes of Health Stage Model and consists of 2 sequential phases, including formative research and the main trial. In phase 1, we will use a participatory human-centered design process that incorporates people living with dementia and their care partners, health care administrators, and clinicians to adapt the CHAT for dementia care (ie, the Dementia CHAT [D-CHAT]; stage IA). In phase 2, we will partner with a large academic medical system to complete a pilot randomized controlled trial to examine the feasibility and estimate the size of the effect of the D-CHAT on care partners’ preparedness for caregiving (stage IB). We anticipate this study to take approximately 60 months to complete, from study start-up procedures to dissemination. The 2 phases will take place between December 1, 2022, and November 30, 2027.

RESULTS: The study protocol will yield (1) a converged-upon, ready-for-feasibility testing D-CHAT; (2) descriptive and feasibility characteristics of delivering the D-CHAT; and (3) effect size estimates of the D-CHAT on care partner preparedness. We anticipate that the resultant D-CHAT will provide clinicians with guidance on how to identify and better prepare care partners for hospitalized people living with dementia. In turn, care partners will feel equipped to fulfill caregiving roles for their family members or friends living with dementia.

CONCLUSIONS: The expected results of this study are to favorably impact hospital-based care processes and outcomes for people living with dementia and their care partners and to elucidate the essential caregiving role that so many care partners of people living with dementia assume.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05592366; https://clinicaltrials.gov/ct2/show/NCT05592366.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46808.

PMID:37347517 | DOI:10.2196/46808

Epilepsia. 2023 Jun 22. doi: 10.1111/epi.17689. Online ahead of print.

ABSTRACT

OBJECTIVES: Although hemispheric surgeries are among the most effective procedures for drug-resistant epilepsy (DRE) in the pediatric population, a large variability in outcomes remains. Identifying ideal hemispherectomy candidates is imperative to maximize the potential for seizure freedom. The objective was to develop an online, freely-accesible tool that accurately predicts the probability of seizure freedom for any patient at 1-, 2-, and 5-years post-hemispherectomy to provide clinicians accessible and reliable prognostic information to complement clinical judgement.

METHODS: Retrospective data of all pediatric patients with DRE and seizure outcome data from the original Hemispherectomy Outcome Prediction Scale (HOPS) study were included. The primary outcome of interest was time-to-seizure recurrence. A multivariate Cox proportional-hazards regression model was developed to predict the likelihood of post-hemispheric surgery seizure freedom duration based on a combination of variables identified by clinical judgement and inferential statistics as predictive of the primary outcome. The final model from this study was encoded in a publicly accessible online calculator on the (iNEST) website.

RESULTS: The selected variables for inclusion in the final model included the 5 original HOPS variables (age at seizure onset, etiologic substrate, seizure semiology, prior non-hemispheric resective surgery, and contralateral FDG-PET hypometabolism) and 3 additional variables (age at surgery, history of infantile spasms, and magnetic resonance (MR) imaging lesion). Predictors of shorter time-to-seizure recurrence included younger age at seizure onset, older age at surgery, prior resective surgery, generalized seizure semiology, FDG-PET hypometabolism contralateral to side of surgery, contralateral MR imaging lesion, non-lesional MR imaging, non-stroke etiologies, and history of infantile spasms. The area under the curve (AUC) of the final model was 73.0%.

SIGNIFICANCE: Online calculators are efficient, cost-free tools that can facilitate physicians in risk-estimation and inform joint decision-making with families, potentially leading to greater satisfaction. Although the HOPS data was previously validated in the first analysis, the authors encourage prospective external validation of this new tool.

PMID:37347512 | DOI:10.1111/epi.17689

Health Care Women Int. 2023 Jun 22:1-16. doi: 10.1080/07399332.2023.2223147. Online ahead of print.

ABSTRACT

In this post-hoc analysis of the AXEPT study, 855 patients were analyzed, 544 (63.6%) females. The mean (± SD) MMSE score in women vs men was 20.8 ± 2.6 vs. 21.2 ± 2.5; p = 0.0087, and women were more likely affected by psychiatric disorders (n = 76, 14.0% women vs. n = 21, 6.8% men; p = 0.0015). Men were mainly assisted by their wives (n = 207, 66.6%), women mainly by their daughters (n = 243, 44.7%) and only in a minority of cases by their husbands (n = 92, 16.9%). Women less frequently cohabited with their caregivers than men (n = 233, 43.1% vs. n = 240, 77.9%, p < 0.0001), and received less daily time of caregiving (mean (± SD): 10.0 ± 7.2 vs. 15.2 ± 8.2; p < 0.0001). No gender differences were highlighted in compliance to treatment and caregiver satisfaction, while gender differences in caregiving were found at disadvantage of women affected by more severe cognitive and psychiatric conditions.

PMID:37347493 | DOI:10.1080/07399332.2023.2223147

JAMA Netw Open. 2023 Jun 1;6(6):e2319359. doi: 10.1001/jamanetworkopen.2023.19359.

ABSTRACT

IMPORTANCE: A cancer diagnosis is associated with substantial economic burden for patients and their families. Young adult cancer survivors with dependent children may be particularly vulnerable to financial hardship.

OBJECTIVE: To examine associations of parental cancer with their children’s unmet economic needs.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from the nationally representative 2013 to 2018 US National Health Interview Survey. Children aged 5 to 17 years living in families with and without parental cancer history were queried about recent 1-year experiences. Statistical analyses were conducted from January 2022 to April 2023.

EXPOSURE: Parental cancer history.

MAIN OUTCOMES AND MEASURES: The main outcomes were children’s unmet economic needs, including family-level food insecurity, parent’s financial worry about paying for monthly bills and housing costs, and delayed child medical care owing to lack of transportation. Multivariable logistic regressions adjusted for (1) child’s characteristics (ie, age group, sex, and race and ethnicity), (2) parent’s characteristics (ie, age group, sex, health insurance coverage, comorbid conditions, and obesity status), and (3) family’s characteristics (ie, family structure [married or cohabiting parents vs single parent families], highest educational attainment in the family, and family income). Additional analyses focused on children with a parental cancer history to identify potentially modifiable characteristics associated with unmet economic needs.

RESULTS: In this cross-sectional study of 22 941 children with (812 children; weighted number, 860 488 children) and without (22 129 children; weighted number, 24 545 463 children) a parental cancer history, the majority of children were aged 5 to 11 years (12 022 children [52.4%]), male (11 920 children [52.0%]), and non-Hispanic White (11 863 children [51.7%]). In adjusted analyses, parental cancer history was associated with more severe family-level food insecurity, including worrying about food running out (odds ratio [OR], 1.97; 95% CI, 1.56-2.49; P < .001), food not lasting (OR, 2.01; 95% CI, 1.56-2.58; P < .001), and inability to afford balanced meals (OR, 1.38; 95% CI, 1.06-1.79; P = .02). Moreover, parental cancer history was associated with parent’s worry about paying monthly bills (OR, 1.41; 95% CI, 1.15-1.74; P = .001) and housing-related costs (OR, 1.31; 95% CI, 1.07-1.60; P = .009) and delays in child medical care because of lack of transportation (OR, 2.31; 95% CI, 1.49-3.59; P < .001). Among children with parental cancer history, female children, non-Hispanic Black children, children whose parents had multiple comorbidities, and children living in low-income families were especially vulnerable to unmet economic needs.

CONCLUSIONS AND RELEVANCE: Parental cancer is associated with greater likelihood of food insecurity, unaffordability of housing and other necessities, and transportation barriers to medical care for minor children. Strategies to identify such children and address their needs are warranted.

PMID:37347484 | DOI:10.1001/jamanetworkopen.2023.19359

JAMA Oncol. 2023 Jun 22. doi: 10.1001/jamaoncol.2023.1648. Online ahead of print.

ABSTRACT

IMPORTANCE: Patient withdrawal of consent from a cancer clinical trial is defined as a patient’s volitional cessation of participation in all matters related to a trial. It can undermine the trial’s purpose, make the original sample size and power calculations irrelevant, introduce bias between trial arms, and prolong the time to trial completion.

OBJECTIVE: To report rates of and baseline factors associated with withdrawal of consent among patients in cancer clinical trials.

DESIGN, SETTING, AND PARTICIPANTS: This multisite observational cohort study was conducted through the Alliance for Clinical Trials in Oncology. Patient withdrawal was defined as a patient’s voluntary termination of consent to participate anytime during trial conduct. Baseline patient- and trial-based factors were investigated for their associations with patient withdrawal within the first 2 years using logistic regression models. All patients who participated in cancer therapeutic clinical trials conducted within the Alliance for Clinical Trials in Oncology from 2013 through 2019 were included. The data lock date was January 23, 2022.

MAIN OUTCOMES AND MEASURES: The percentage of patients who withdrew consent in 2 years and factors associated with withdrawal of consent.

RESULTS: A total of 11 993 patients (median age, 62 years; 67% female) from 58 trials were included. Within 2 years, 1060 patients (9%) withdrew from their respective trials. Two-year rates of withdrawal were 5.7%, 7.6%, 8.5%, 7.8%, 8.4%, 9.5%, and 9.8% for each of the respective years from 2013 through 2019. In multivariable analyses, Hispanic ethnicity (odds ratio [OR], 1.67; 95% CI, 1.30-2.15; P < .001), randomized design with placebo (OR, 1.64; 95% CI, 1.38-1.94; P < .001), and patient age 75 years and older (OR, 1.39; 95% CI, 1.12-1.72; P = .003) were associated with higher likelihood of withdrawal by 2 years. Use of radiation was associated with patient retention (OR, 0.68; 95% CI, 0.54-0.86; P = .001).

CONCLUSIONS AND RELEVANCE: In this cohort study, rates of withdrawal of consent were less than 10% and appeared consistent over time. Factors that are associated with withdrawal of consent should be considered when designing trials and should be further studied to learn how they can be favorably modified.

PMID:37347469 | DOI:10.1001/jamaoncol.2023.1648